What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation include pharmacologic therapies like antiarrhythmic drugs and non-pharmacologic therapies such as catheter ablation. Antiarrhythmic drugs, including amiodarone, sotalol, and dronedarone, can cause side effects such as bradycardia, QT interval prolongation, and increased risk of cardiovascular events. Catheter ablation, including the FARAPULSE Pulsed Field Ablation System, may lead to complications like vascular access issues, cardiac tamponade, and pulmonary vein stenosis. Both treatment types require careful monitoring to manage and mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation, including antiarrhythmic drugs and catheter ablation techniques. Antiarrhythmic drugs such as amiodarone, sotalol, dofetilide, and dronedarone have been approved to maintain sinus rhythm in AF patients. However, dronedarone has specific restrictions due to increased cardiovascular risks in certain populations. Catheter ablation, particularly radiofrequency ablation (RFA), has also been approved and is considered effective for rhythm control in AF, especially in patients with co-existing heart failure and reduced ejection fraction. The FARAPULSE Pulsed Field Ablation System represents a newer, investigational approach within this category, aiming to improve safety and efficacy in treating persistent AF.

What other types of research exist?

Promising novel alternatives to the FARAPULSE Pulsed Field Ablation System for treating atrial fibrillation include: 1) Hybrid Ablation, which combines epicardial and endocardial approaches for more comprehensive treatment, and 2) Cryoballoon Ablation, which uses cryotherapy to isolate pulmonary veins and has shown reliable short and midterm outcomes. Both methods offer advanced, non-pharmacological options for AF management.

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Pulsed Field Ablation System

FARAPULSE Ablation for Atrial Fibrillation (ADVANTAGE AF Trial)

N/A

Waitlist Available

Led By Vivek Reddy

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as: a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III). c. Persistent: continuous AF for > 7 days and ≤ 365 days

Age ≥ 18 years of age, or older if specified by local law

Must not have

Contraindication to ICM insertion: Patients who cannot tolerate a subcutaneous, chronically-inserted LUX-Dx device

Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 360 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that uses electrical pulses to treat patients with persistent atrial fibrillation who do not respond to drugs. The device works by creating small scars in the heart to block abnormal electrical signals and restore normal rhythm.

Who is the study for?

This trial is for adults with symptomatic, drug-resistant persistent atrial fibrillation (AF) that's been continuous for more than 7 days but less than a year. Participants must have tried at least one antiarrhythmic drug without success and be able to attend all study-related tests. Exclusions include secondary AF due to reversible causes, severe heart conditions, certain pre-existing medical devices or implants, recent stroke or bleeding events, pregnancy, uncontrolled health issues like diabetes or sleep apnea, and those currently in other conflicting studies.

What is being tested?

The ADVANTAGE AF Study is testing the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System as a treatment option for people with persistent AF who haven't responded well to drugs. It's an open-label study where all participants receive the same intervention using this new ablation system designed specifically for their condition.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with ablation procedures may include discomfort at the site of catheter insertion, bleeding or bruising there too; rare chances of serious complications such as damage to blood vessels or heart tissue; potential arrhythmias during recovery; and very rarely stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have persistent AF that's resistant to at least one heart rhythm medication.

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I am at least 18 years old or meet the age requirement by local law.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have a device implanted under my skin for health reasons.

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I have severe lung disease or need extra oxygen.

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I have had a stroke, TIA, or brain bleeding.

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I have a tumor in my heart's left atrium.

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I have had a blood clot that was not in my brain.

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I am currently fighting an infection in my body.

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- You currently have active COVID-19 or have recently had COVID-19 that hasn't fully cleared up. - Your diabetes is not well controlled, or your HgbA1c test result is higher than 8.0% in the last 3 months. - You have severe untreated obstructive sleep apnea, with more than 30 pauses in breathing per hour.

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My kidney function is low, with an eGFR below 30, or I have had dialysis or a kidney transplant.

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I have or had paralysis or weakness of one side of my diaphragm.

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I have had heart surgery.

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I do not have severe stomach or esophagus problems.

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I have a known G6PD deficiency.

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I have had issues with my blood vessels, but not with the common or middle ones.

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I have not had cancer, except for skin cancer, in the last 2 years.

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You have heart valve disease, hypertrophic cardiomyopathy, or certain heart conditions that could cause problems during the study.

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I have had or am being evaluated for an organ or bone marrow transplant.

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I have severe heart failure.

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I am not pregnant, breastfeeding, and I use birth control.

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I have a heart condition from birth with lasting effects.

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I have a blood condition affecting clotting or platelet levels.

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I have had bleeding in my stomach or intestines.

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I have had a procedure to open my carotid artery.

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My heart's left atrium is enlarged.

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I have never had sustained ventricular tachycardia or ventricular fibrillation.

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I have been hospitalized for heart failure.

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I have inflammation or fluid around my heart.

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I cannot or do not want to use blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 360 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~360 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 360 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Rate of Persistent AF Acute Procedural Success

Phase 1: Rate of Persistent AF Chronic Success

Phase 1: Rate of Safety Events at 12 Months Post Procedure

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pulsed Field Ablation (Phase 2)Experimental Treatment1 Intervention

PHASE 2 only

Group II: Pulsed Field Ablation (Phase 1)Experimental Treatment1 Intervention

PHASE 1 only

0 / 29Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atrial Fibrillation (AF) include antiarrhythmic drugs, rate control drugs, and catheter ablation. Antiarrhythmic drugs, such as amiodarone and sotalol, work by altering the electrical signals in the heart to maintain a normal rhythm. Rate control drugs, like beta-blockers and calcium channel blockers, slow the heart rate by affecting the atrioventricular node. Catheter ablation, including the Pulsed Field Ablation (PFA) studied in the FARAPULSE system, targets and destroys small areas of heart tissue that cause irregular electrical signals, thereby restoring normal rhythm. PFA specifically uses electrical pulses to create precise lesions without damaging surrounding tissues, which is crucial for reducing complications and improving outcomes for AF patients.